MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
15
|
16
|
17
|
18
|
19
|
20
|
Tremor
|
Tremor fine
|
very common
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Shakiness
|
9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tremor
|
postmarketing — 0% - 35%
|
0% - 1.1%
|
|
x
|
x
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Tremor muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tremor of hands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
Exacerbation of asthma
|
very rare — 11.1% - 13%
|
8.5%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
postmarketing, 1% - 10%
|
5.1% - 6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Excitement
|
2% - 20%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkinesia
|
very rare — 1% - 4%
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Agitation
|
postmarketing, 1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
Viral infection
|
Viral infection
|
4.7% - 12.3%
|
5.1% - 9.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Bronchospasm
|
Bronchospasm
|
very rare — 8% - 18%
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
Bronchospasm aggravated
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Respiratory tract infection
|
Respiratory tract infection
|
4% - 7%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
postmarketing, 2.2% - 11.1%
|
1.7% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Throat irritation
|
Throat irritation
|
postmarketing — 6% - 10%
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Vomiting
|
Vomiting
|
postmarketing, 1% - 19.8%
|
3.9% - 5.7%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Inflammation
|
Inflammation
|
5%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal pain
|
Musculoskeletal pain
|
3% - 5%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
postmarketing, 0% - 5%
|
0% - 0.9%
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Cough
|
Cough
|
postmarketing, 1% - 5%
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
x
|
Cough increased
|
postmarketing, 1.4% - 4.1%
|
2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Nervousness
|
Nervousness
|
postmarketing, 1% - 20%
|
0% - 2.8%
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing, 1% - 20%
|
0% - 2.8%
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Tension
|
very rare
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Feeling tense
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nausea
|
Nausea
|
postmarketing, 0% - 19.8%
|
0.9% - 3.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Injury
|
Accidental injury
|
0% - 10.3%
|
0% - 5.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
Body temperature increased
|
Body temperature increased
|
postmarketing, 1.6% - 9.1%
|
5.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Headache
|
Headache
|
postmarketing — 1.5% - 35%
|
8.5% - 20.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Increased appetite
|
Increased appetite
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
1.4% - 6.7%
|
1.3% - 3.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dizziness
|
Dizziness
|
postmarketing, 0% - 7%
|
1.3% - 5.1%
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sinusitis
|
Sinusitis
|
1.4% - 4.2%
|
2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Influenza
|
Influenza
|
1.4% - 4.2%
|
0% - 1.7%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dyspepsia
|
Heartburn
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Dyspepsia
|
postmarketing, 0% - 2.7%
|
1.3%
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
Epigastric distress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure increased
|
Blood pressure increased
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Gastroenteritis
|
Gastroenteritis
|
0.9% - 3.4%
|
0.9%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Flatulence
|
Flatulence
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing — 0.5% - 10%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal symptom NOS
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Asthenia
|
Asthenia
|
1% - 3%
|
0%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Fatigue
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasopharyngitis
|
Cold symptoms
|
0% - 3.4%
|
1.7%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasopharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
postmarketing, 0% - 6.7%
|
3.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Stomach ache
|
1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing, 0% - 6.7%
|
3.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diarrhoea
|
Diarrhoea
|
0% - 6%
|
0%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 1.5%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
Wheezing
|
Wheezing
|
1% - 1.5%
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
Myalgia
|
Myalgia
|
postmarketing, 0% - 3.3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
postmarketing, 0% - 3.3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oedema
|
Oedema
|
postmarketing, 0% - 2.8%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
postmarketing, 0% - 2.7%
|
1.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Muscle spasms
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cramp muscle
|
postmarketing — 0.5% - 5%
|
0.6%
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
|
Lymphadenopathy
|
Lymphadenopathy
|
0% - 3%
|
0% - 1.7%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Aggression
|
Aggression
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
postmarketing, 1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Fatigue
|
Fatigue
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
postmarketing, 1% - 3.1%
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasal congestion
|
Nasal congestion
|
1%
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pallor
|
Pallor
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mood swings
|
Mood swings
|
postmarketing, 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Affect lability
|
Mood swings
|
postmarketing, 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperkinesia
|
Hyperkinesia
|
very rare — 1% - 4%
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Insomnia
|
Insomnia
|
postmarketing, 0% - 6.1%
|
1.7%
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Appetite absent
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anorexia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
0% - 2%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Drowsiness
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Migraine
|
Migraine
|
0% - 2.7%
|
0%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Palpitations
|
Palpitations
|
postmarketing — 0% - 22%
|
1.1%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Nightmare
|
Nightmare
|
postmarketing, 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Chest pain
|
Chest pain
|
postmarketing, 0% - 1.7%
|
0%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Flushing
|
Flushing
|
postmarketing, 1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
Irritability
|
Irritability
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Mydriasis
|
Mydriasis
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
postmarketing, 0% - 12.8%
|
2.4% - 6.8%
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
Sweating increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Abdominal pain upper
|
Stomach ache
|
1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Epigastric pain
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chest discomfort
|
Chest discomfort
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Dysuria
|
Strangury
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Strangury
|
Strangury
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Angioedema
|
Angioedema
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
Arrhythmia
|
Arrhythmia
|
very rare — 0% - 3%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
very rare — rare
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Coagulopathy
|
Coagulopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infection
|
Infection
|
postmarketing, 0% - 1.7%
|
0%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Taste altered
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis
|
Rash
|
postmarketing, 0% - 7.5%
|
0%
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 0% - 7.5%
|
0%
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Retching
|
Gagging
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glossitis
|
Glossitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysphonia
|
Hoarseness
|
postmarketing
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
x
|
|
Dysphonia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
very rare — 0% - 3.4%
|
1.3% - 1.7%
|
x
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing, rare
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
Hypotension
|
Hypotension
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
|
Breast pain
|
Breast pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal disorder
|
Musculoskeletal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pruritus
|
Pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin disorder
|
Skin disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
very rare — rare
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Tracheitis
|
Tracheitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Urticaria
|
Urticaria
|
very rare — 0% - 3%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Vertigo
|
Vertigo
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Application site reaction
|
Application site reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue discolouration
|
Tongue discolouration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Metabolic acidosis
|
Metabolic acidosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Malaise
|
Malaise
|
postmarketing, 0% - 1.5%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Discomfort
|
Malaise
|
postmarketing, 0% - 1.5%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Feeling abnormal
|
Malaise
|
postmarketing, 0% - 1.5%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing, 0% - 1.5%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Thinking abnormal
|
Thinking abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mental disability
|
Thinking abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Euphoric mood
|
Euphoric mood
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue ulceration
|
Tongue ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Saliva altered
|
Saliva altered
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchospasm paradoxical
|
Bronchospasm paradoxical
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
Extrasystoles
|
Extrasystoles
|
very rare — rare
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Oropharyngeal swelling
|
Oropharyngeal swelling
|
postmarketing
|
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Autonomic neuropathy
|
Unspecified disorder of autonomic nervous system
|
postmarketing, 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vasodilatation
|
Peripheral vasodilatation
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Lactic acidosis
|
Lactic acidosis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Anxiety
|
Anxiety
|
0% - 2.7%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Ataxia
|
Ataxia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Back pain
|
Back pain
|
0% - 2.7%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Constipation
|
Constipation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear disorder
|
Ear disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Eczema
|
Eczema
|
0% - 3.3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eructation
|
Eructation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Glycosuria
|
Glycosuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cardiac murmur
|
Cardiac murmur
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes simplex
|
Herpes simplex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperaesthesia
|
Hyperaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Type I hypersensitivity
|
Type I hypersensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
Hyperventilation
|
Hyperventilation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Eye pruritus
|
Eye pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ketosis
|
Ketosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngitis
|
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Lung disorder
|
Lung disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypertonia
|
Hypertonia
|
0% - 2.7%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Otitis media
|
Otitis media
|
0% - 4.3%
|
0% - 1.7%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-eclampsia
|
Pre-eclampsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Multiple pregnancy
|
Multiple pregnancy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Shock
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Vasodilation procedure
|
Vasodilation
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Cardiac output increased
|
Cardiac output increased
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac failure high output
|
Cardiac output increased
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Rigors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Myocardial ischaemia
|
Myocardial ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cardiac fibrillation
|
Cardiac fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry throat
|
Dry throat
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Tachycardia foetal
|
Tachycardia foetal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram ST segment depression
|
Electrocardiogram ST segment depression
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Fluid overload
|
Fluid overload
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling hot
|
Sensation of warmth
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Emotional distress
|
Emotional distress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram change
|
Electrocardiogram change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Vascular resistance systemic
|
Vascular resistance systemic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Ileus
|
Ileus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|